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ScabiesVSEEPNCT00604084

Veron Scabies Education and Eradication Program

A study testing Ivermectin and Permethrin 5% lotion in people with Scabies, run by Edward Via Virginia College of Osteopathic Medicine at 1 site in Dominican Republic.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this project is to develop a community scabies eradication and education program for the highly endemic areas surrounding the Veron community on the eastern tip of the Dominican Republic. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Scabies
What is being tested?
Ivermectin and Permethrin 5% lotion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,057 participants
Where
1 siteDominican Republic
Study dates
May 2007to May 2008
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • IVERMECTIN ARM:
  • able to swallow pills
  • no known allergy to Ivermectin
  • not pregnant
  • not breastfeeding
  • 5 years or older
Show all 16Show fewer
  • taller than 90cm
  • willingness to participate in study and give written consent
  • PERMETHRIN ARM:
  • no known allergy to Permethrin 5% lotion
  • able to apply lotion to self or to other person if a child
  • pregnant
  • breastfeeding
  • younger than 5 years
  • shorter than 90cm
  • willingness to participate in study and give written consent

Who cannot join

  • IVERMECTIN ARM:
  • unable to swallow pills
  • allergy to Ivermectin
  • pregnant
  • breastfeeding
  • younger than 5 years
Show all 16Show fewer
  • shorter than 90cm
  • unwilling to participate in study or give written consent
  • PERMETHRIN ARM:
  • unable to apply lotion to self
  • allergy to Permethrin 5% lotion
  • not pregnant
  • not breastfeeding
  • 5 years or older
  • taller than 90cm
  • unwilling to participate in study or give written consent

Trial locations and contacts

1 site in 1 country.

Dominican Republic1 site
  • Barrio Nuevo

    Veron, La Altagracia Province

Other trials in Dominican Republic

About this study

The purpose of this project is to develop a community scabies eradication and education program for the highly endemic areas surrounding the Veron community on the eastern tip of the Dominican Republic. It proposes the use of oral Ivermectin as a replacement for topical Lindane--a readily available medical formulation, pesticide, and environmental toxin that is reported to be banned in the Dominican Republic as well as over 80 other countries throughout the world.

Read the detailed description

Introduction

The Secretaría de Estado de Salud Pública y Asistencia Social public health clinic in Veron, Dominican Republic continually reports a subjectively high prevalence and incidence of scabies infections among its general patient population without any means of direct measurement, proper intervention, or control, raising concerns that long-term infestation may lead to multiple other secondary medical and environmental problems.

The purpose of this project is to develop a community scabies eradication and education program for the highly endemic areas surrounding the Veron community. It proposes the use of oral Ivermectin as a replacement for topical Lindane, a readily available and prescribed pesticide and environmental toxin that is reportedly banned for all uses in the Dominican Republic as well as over 80 other countries throughout the world (Boffa, Brough, \& Ead, 1995; Davies, Dedhia, Mergade, Banquet, \& Maibach, 1983).

Ivermectin, on the other hand, is a remarkably safe, effective, cost-comparative oral medication with a substantially broader scope of coverage, duration of effectiveness, and ease of delivery and compliance when compared to Lindane, as well as over 20 years of use in global mass eradication campaigns for other parasites on the order of more than 50 million doses to date (Alexander, Bockarie, Kastens, Kazra, \& Alpers, 1998; del Guidice, Chosidow, \& Caumes, 2003; Madan, Jaskiran, Gupta, \& Gupta, 2001).

Specific program goals include: the quantification of community disease prevalence, a statistically significant reduction in both scabies incidence as well as secondary disease sequelae, improved community scabies awareness and prevention abilities, and decreased environmental impact on the Veron area by eliminating the use of Lindane for scabies treatment.

The research is designed to employ a door-to-door survey and treatment campaign in a typical Veron neighborhood aimed at evaluating and treating every member in this target population to create a mass prophylaxis that breaks the parasite-host cycle. Another round of treatment will occur 6 months later, per pharmacologic dosage interval recommendations (del Guidice et al., 2003).

Individual and group scabies education programs will occur at the Veron clinic, as well as at the local schools to target the highly susceptible youth populations throughout the Veron area.

Incidence measurements will occur on a monthly basis for one year after program start, coinciding with two 6-month treatment intervals. At the end of one year, final scabies prevalence and incidence data will be evaluated for statistical significance. While mass treatments will cease at this time, oral Ivermectin will become the standard of care for ectoparasite coverage at the Veron clinic assuming a statistically significant reduction in scabies prevalence is achieved.

To date, no mass scabies eradication programs using oral Ivermectin have been reported in the Caribbean, despite it remarkable success in other countries against scabies as well as other parasites, namely onchocerciasis and filariasis (Walker \& Johnstone, 2000; Walton \& Holt, 2004). This project has the potential to be an important contribution to the effort to eradicate a source of significant morbidity for both the people of Veron and the global community as a whole.

Methodology

The Veron Scabies Eradication and Education Program will obtain all its priority population data via door-to-door interviews within the Barrio Nuevo neighborhood.

A survey team of medical personnel will walk door-to-door program in an attempt to survey and treat every inhabitant of Barrio Nuevo, unless there is refusal or absolute contraindications. Subjects will first be informed of the program and its intent, asked to sign a letter of patient confidentiality, and assigned a number identifier for tracking purposes.

After consent is obtained, a survey will be administered to collect basic demographic information, scabies knowledge indicators, as well as pertinent past and current medical history related to scabies infection and contraindications to treatment with Ivermectin.

The subject will then be asked to undergo a brief skin exam that assesses scabies infectivity and results recorded using the following criteria: the presence of erythematous popular, vesicular, pustular, or bullous lesions associated with itching. Information will be recorded and used to guide treatment protocol.

After the skin exam, subjects will be instructed on scabies medical treatment and prevention, given a patient information and education pamphlet, asked if they have any specific questions or concerns, informed of ongoing community scabies education workshops at the clinic, and instructed to return to the clinic in 2 weeks if they have an active scabies infection. Otherwise, they will be informed that the researchers will return to their neighborhood each month to collect more information and in 6 months to administer another treatment.

Finally, the subject will be given 200μg/kg oral Ivermectin dosed by height if they are male or non-pregnant/non-lactating female, 5 years of age or older, and taller than 90 cm.

If the subject is a female and of childbearing age (still menstruating on a monthly basis), not currently menstruating, not able to show proof of using oral contraceptives (birth control pills) or injectable contraceptives (scheduled Depo Provera), not surgically sterile (hysterectomy or tubal ligation) they will be asked to undergo a rapid urine pregnancy test. If the test is negative they will be given 200μg/kg oral Ivermectin dosed by height.

If the subject is knowingly pregnant or lactating, the rapid pregnancy test is positive, or a child under 5 years and shorter than 90 cm they will be instructed on how to properly use Permethrin 5% lotion and given a 60gm bottle.

This protocol will be followed until every household is visited and treated within Barrio Nuevo at time = 0 and again at time = 6 months.

Investigators will conduct monthly scabies incidence surveys via door-to-door skin checks within Barrio Nuevo looking for current scabies symptomatology and recording results on the form described above.

At the end of one year, final scabies prevalence and incidence data will be evaluated for statistical significance. While mass treatments will cease at this time, oral Ivermectin will become the standard of care for ectoparasite coverage at the Veron clinic assuming a statistically significant reduction in scabies prevalence is achieved.

Conditions
Scabies
Being tested
Ivermectin, Permethrin 5% lotion
Keywords
Scabies, Ivermectin, Lindane, Mass Eradication
Medical subject headings
Scabies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IvermectinDrug

    Also called Ivermectina

    Ivermectin 200ug/kg, 1 dose Q 6 months x 2, total duration = 12 months

  • Permethrin 5% lotionDrug

    Also called Permethrina locion

    apply lotion to entire body, excluding head, at bedtime, rinse off following morning, wait one week, repeat application for a total of 2 applications, PRN frequency, NMT 6 applications in 12 months, total duration = 12 months.

Study groups in NCT00604084
Study groupRoleWhat they receive
IvermectinExperimentalNon-pregnant, non-breastfeeding, taller than 90cm and 5 years or older
Receives: Drug: Ivermectin
PermethrinExperimentalPregnant, breastfeeding, children under 90cm or under 5 years old
Receives: Drug: Permethrin 5% lotion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Scabies incidence

    Measured: monthly

Secondary outcomes (4)
  1. Scabies-induced skin abscess incidence

    Measured: monthly

  2. Incidence of Lindane prescription and use

    Measured: monthly

  3. Incidence of Ivermectin prescription and use

    Measured: monthly

  4. Scabies disease, treatment, and prevention awareness

    Measured: monthly

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2008 (estimated)
  2. Study startMay 2007
  3. Primary completionMay 2008
  4. Study completionMay 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
1,057 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00604084
Sponsor's protocol ID
IRB#2007/006
Acronym
VSEEP
Status last verified
Jul 2019
First submitted
16 Jan 2008
Last updated
22 Jul 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Boffa MJ, Brough PA, Ead RD. Lindane neurotoxicity. Br J Dermatol. 1995 Dec;133(6):1013. doi: 10.1111/j.1365-2133.1995.tb06950.x. No abstract available.

    PubMed 8547026
  • Davies JE, Dedhia HV, Morgade C, Barquet A, Maibach HI. Lindane poisonings. Arch Dermatol. 1983 Feb;119(2):142-4. doi: 10.1001/archderm.1983.01650260050017.

    PubMed 6186202
  • Alexander ND, Bockarie MJ, Kastens WA, Kazura JW, Alpers MP. Absence of ivermectin-associated excess deaths. Trans R Soc Trop Med Hyg. 1998 May-Jun;92(3):342. doi: 10.1016/s0035-9203(98)91035-5. No abstract available.

    PubMed 9861413
  • del Giudice P, Chosidow O, Caumes E. Ivermectin in dermatology. J Drugs Dermatol. 2003 Jan;2(1):13-21.

    PubMed 12852376
  • Madan V, Jaskiran K, Gupta U, Gupta DK. Oral ivermectin in scabies patients: a comparison with 1% topical lindane lotion. J Dermatol. 2001 Sep;28(9):481-4. doi: 10.1111/j.1346-8138.2001.tb00015.x.

    PubMed 11603388
  • Walker GJ, Johnstone PW. Interventions for treating scabies. Cochrane Database Syst Rev. 2000;(3):CD000320. doi: 10.1002/14651858.CD000320.

    PubMed 10908470
  • Walton SF, Holt DC, Currie BJ, Kemp DJ. Scabies: new future for a neglected disease. Adv Parasitol. 2004;57:309-76. doi: 10.1016/S0065-308X(04)57005-7.

    PubMed 15504541

Questions about this trial

What is this clinical trial studying?

A study testing Ivermectin and Permethrin 5% lotion in people with Scabies, run by Edward Via Virginia College of Osteopathic Medicine at 1 site in Dominican Republic.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Dominican Republic. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Scabies incidence (time frame: monthly). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00604084, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2019.

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